The Sr. QA Specialist will be responsible for daily QA tasks at the direction and under the supervision of the Manager of Quality Systems to support the development, implementation, and maintenance of the company quality assurance program. The Sr. QA Specialist may perform initial review and preparation of records and events, but is not responsible or authorized to perform technical approvals, high-level Quality decisions, or release of GxP material or documentation, except where specifically authorized in writing by the Quality Systems Manager.
Primary Responsibilities Include:
Actively contribute to all Quality Systems such as Deviations, Change Control, Out-of-Specifications, CAPA, Training, and Risk Assessments
Collaborate with other departments to fully support Equipment Qualification and Calibration programs
Involvement with controlled document systems, including authoring and revising SOPs
Lead or assist with continuous improvement initiatives across all GMP functions
Lead or assist in auditing and investigation activities, perform root-cause analyses, and help to develop corrective and preventative action plans
Preparation of trend reports across Quality Systems, as needed
Provide support during Regulatory inspections and client audits
Assist in maintaining the facility in an inspection-ready state
Job Qualifications and Requirements
A Bachelor's degree in Science, preferably in biology or similar field
At least two years of working within the pharmaceutical or biotechnology industry, in a GMP environment
GLP experience preferable
Strong understanding of GMPs
Quality Systems experience in GMP environment An ability to organize, understand, and present complex scientific and technical information at a level that is appropriate for technical and non-technical backgrounds Attention to detail and analytical thinking Excellent communication and interpersonal skills Excellent organizational skills Experience in Regulatory Inspection participation a plus
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
